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A Study of Tocilizumab in Patients With Rheumatoid Arthritis

Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01187563
Collaborator
(none)
16
Enrollment
2
Locations
4
Duration (Months)
8
Patients Per Site
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an open-label, uncontrolled, observational study in patients with rheumatoid arthritis (RA) who are receiving tocilizumab concomitantly with methotrexate as part of their standard of care.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This single arm, open label study evaluates the safety and pharmacodynamic profile of tocilizumab in RA patients. Participating patients are among those for whom tocilizumab is indicated and who are scheduled to receive tocilizumab as part of their normal care, in full compliance with the FDA-approved prescribing information. Study assessments consist of clinical evaluations and laboratory tests conducted in conjunction with the first three monthly intravenous infusions of tocilizumab. These assessments are designed to provide a better understanding of the pharmacodynamic effects and mechanistic actions of tocilizumab and help guide the clinical development of other therapeutic agents for RA. A total of 15 patients are expected to participate for approximately 10 weeks.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    16 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Phase 4, Open-label, Repeat-Dose Study of the Safety and Pharmacodynamic Profile of Tocilizumab and Concomitant Methotrexate in Patients With Rheumatoid Arthritis
    Study Start Date :
    Aug 1, 2010
    Actual Primary Completion Date :
    Dec 1, 2010
    Actual Study Completion Date :
    Dec 1, 2010

    Outcome Measures

    Primary Outcome Measures

    1. Safety (clinical and laboratory parameters) [Throughout the study until week 10]

      Proportion of patients with neutropenia, elevated transaminase, and/or decreased platelet count

    Secondary Outcome Measures

    1. Treatment emergent adverse events [Throughout the study until week 10]

      Post-baseline changes in vital signs, and hematological and biochemical parameters

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • ≥ 18 years of age

    • Moderately to severely active rheumatoid arthritis

    • Inadequate response to previous treatment with an anti-TNF agent

    • Receiving methotrexate for at least 12 wks before study

    Exclusion Criteria:

    • Previous treatment with tocilizumab

    • Previous treatment with other IL-6 receptor inhibitors

    • Treatment with corticosteroids (oral prednisone >10 mg/day or equivalent) within 4 wks

    • Conditions noted in the tocilizumab prescribing information

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Worcester Massachusetts United States
    2 Duncansville Pennsylvania United States

    Sponsors and Collaborators

    • Regeneron Pharmaceuticals

    Investigators

    • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Regeneron Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT01187563
    Other Study ID Numbers:
    • 0000-RA-1008
    First Posted:
    Aug 24, 2010
    Last Update Posted:
    Oct 13, 2011
    Last Verified:
    Oct 1, 2011
    Keywords provided by Regeneron Pharmaceuticals
    Rheumatoid arthritis, tocilizumab
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid

    Study Results

    No Results Posted as of Oct 13, 2011